Shaikh Salman
Regulatory Affairs Specialist at ALRAZI PHARMA INDUSTRIES- Claim this Profile
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Bio
Credentials
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Pharmacist
North Maharashtra University
Experience
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ALRAZI PHARMA INDUSTRIES
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Saudi Arabia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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Sep 2022 - Present
Preparation of dossier for GCC. Handling of queries received from client & MOH. Reviewing of artworks, PIL & SPC etc. Review of quality documents like DMF, QQF, PV, RMS/STP’s, FPS/STP’s, PMS/GTP, Stability, CCF etc. Reviewing of safety documents like non-clinical data. Reviewing of efficacy documents like BE Study & CDP. Co-ordination with concerned departments for the documents. Maintenance of Daily Work Report, Export Registration Sheet, Query Sheet etc. Tender work. Preparation of dossier for GCC. Handling of queries received from client & MOH. Reviewing of artworks, PIL & SPC etc. Review of quality documents like DMF, QQF, PV, RMS/STP’s, FPS/STP’s, PMS/GTP, Stability, CCF etc. Reviewing of safety documents like non-clinical data. Reviewing of efficacy documents like BE Study & CDP. Co-ordination with concerned departments for the documents. Maintenance of Daily Work Report, Export Registration Sheet, Query Sheet etc. Tender work.
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ZIM LABORATORIES LIMITED
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India
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Regulatory Affairs Officer
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Mar 2021 - Aug 2022
Preparation of dossier for ROW market (African, ASEAN, Caribbean, CIS, Francophone, GCC, LATAM, MENA, SAARC etc.) as per CTD, eCTD, ACTD, & country specific guidelines. Handling of queries received from client & MOH. Arrangement of PP, COPP, FSC, POA, WS, COA & other legal documents. Reviewing of administrative documents like LOA, POA, PP, COPP, FSC, commitment/declarations, artworks, PIL etc. Review of quality documents like DMF, QQF, PDR, PV, RMS/STP’s, FPS/STP’s, AMV, PMS/GTP, Stability, CCF, bulk material transfer, etc. Reviewing of safety documents like non-clinical data. Reviewing of efficacy documents like BE Study & CDP. Co-ordination with concerned departments for the documents. Maintenance of Daily Work Report, Export Registration Sheet, Query Sheet etc. Preparation of MSDS. Tender work. Show less
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Pelltech Healthcare
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Executive
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Oct 2020 - Mar 2021
Preparation & compilation of dossiers as per ACTD, CTD & country specific guidelines for ROW market.Coordination with concerned departments for documents. Reviewing of administrative & technical documents like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Packing Record, Master Formula Record, and Stability Data etc. with respective of their approvability from the agency.Literature searching for Clinical and Non-Clinical data and prepare report.Arrangement of product samples as per country guidelines/client requirements.Artworks development for local market, export registration & commercial products as per country/client requirements.Artwork development & proofing, shade card approvals, MPC, PMS, SOP & MIS preparation.Allocation of shippers to commercial products.Preparation of Material Safety Data Sheet.Update status of dossier for company record.Maintain records of artworks, shade cards, printing, packing material specifications etc.Allocation of barcodes & codes to printed packing material.Consultation with vendors & purchase department for printing of packing material. Show less
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Regulatory Affairs Officer
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Sep 2019 - Sep 2020
Preparation & compilation of dossiers as per ACTD, CTD & country specific guidelines for ROW market.Coordination with concerned departments for documents. Reviewing of administrative & technical documents like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Packing Record, Master Formula Record, and Stability Data etc. with respective of their approvability from the agency.Literature searching for Clinical and Non-Clinical data and prepare report.Arrangement of product samples as per country guidelines/client requirements.Artworks development for local market, export registration & commercial products as per country/client requirements.Artwork development & proofing, shade card approvals, MPC, PMS, SOP & MIS preparation.Allocation of shippers to commercial products.Preparation of Material Safety Data Sheet.Update status of dossier for company record.Maintain records of artworks, shade cards, printing, packing material specifications etc.Allocation of barcodes & codes to printed packing material.Consultation with vendors & purchase department for printing of packing material. Show less
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Trainee - Regulatory Affairs
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Jan 2019 - Aug 2019
Responsibilities:Preparation & compilation of product registration & re-registration dossiers as per ACTD, CTD & country specific guidelines for ROW market. Management of Product Life Cycle from Regulatory perspectives. Co-ordination with manufacturing plant concerned departments for documents. Reviewing of administrative & technical documents like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Packing Record, Master Formula Record and Stability Data etc. with respective of their approvability from the agency. Preparation of pack inserts, summary of product characteristics and patient information leaflet. Preparation of Material Safety Data Sheet. Literature searching for Clinical and Non-Clinical data and prepare report. Update status of dossier for company record. Arrangement of product samples as per country guidelines/client requirements. Prepare & compile responses enquiries, requests & demands from external parties (e.g. Regulatory Authorities, Distributor/Partners etc.)Artworks preparation for local market, export registration & commercial products as per country/client requirements. Artwork & Shade card approval. Master Packing Card, Packing Material Specification, SOP & MIS report preparation. Innovators sample analysis. Maintain records of artworks, shade cards, printing, packing material specifications etc. Allocation of barcodes & codes to printed packing material. Consultation with vendors & purchase department for printing of packing material. Allocation of shippers to commercial products. Show less
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Target Educational Consultancy, Thane
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Thane, Maharashtra, India
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Lecturer - D. Pharm
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Sep 2017 - Dec 2018
Responsible for preparing lesson plans and educate students as per the syllabus of DTEB. Develop and issue educational content including notes, tests, and assignments. Deliver personalized instruction to each student by encouraging interactive learning. Attend parent-teacher meetings. Evaluate and document students? progress. Allocate and grade homework, assignments, and tests. Responsible for preparing lesson plans and educate students as per the syllabus of DTEB. Develop and issue educational content including notes, tests, and assignments. Deliver personalized instruction to each student by encouraging interactive learning. Attend parent-teacher meetings. Evaluate and document students? progress. Allocate and grade homework, assignments, and tests.
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Cadila Pharmaceuticals Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Technical Trainee - Packaging & Development
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Mar 2017 - Aug 2017
Artwork, shade card & final sample approval. Final packing inspection in formulation plant. Master Manufacturing Docket-II, Packing Material Specification & SOP preparation. Innovator sample analysis. Maintain documentation. GTIN no. generation & allocation of codes to printed packing material. Allocation of shipper to products.
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Apprentice - Packaging & Development
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Aug 2016 - Feb 2017
Artwork, shade card & final sample approval. Final packing inspection in formulation plant. Master Manufacturing Docket-II, Packing Material Specification & SOP preparation. Innovator sample analysis. Maintain documentation. GTIN no. generation & allocation of codes to printed packing material. Allocation of shipper to products.
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Education
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2015 - 2016
North Maharashtra University
M. Pharm, Pharmaceutics -
2011 - 2014
North Maharashtra University
B. Pharm, Pharmacy -
2009 - 2010
Amravati Board
HSC, 64.17 -
2007 - 2008
Amravati Board
SSC, 69.23
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